LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option — Class II medical device recall Z-1143-2017
Terminated recall by Physio-Control, Inc., reported 2017-02-15, distributed nationwide. The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device opera
| Recall number | Z-1143-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Physio-Control, Inc., Redmond, WA, United States |
| Recall initiated | 2017-01-16 |
| Classified | 2017-02-07 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2018-09-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BE, BH, CA, CH, CL, CZ, DE, DK, DZ, ES, FI, FR, GB, GR, HU, IE, IS, IT, LT, LU, NL, NO, NZ, PL, PT, RS, SA, SI, ZA |
| Lot numbers | 1520, 1544 |
Product
LIFEPAK 12 Defibrillator/Monitor with End-Tidal CO2 option. The device is used in various areas of the hospital such as critical areas (emergency departments, critical care, operating room, etc.) and general duty floors (e.g. medical/surgical). The device is also used for in and out of hospital transport (air and ground ambulance, in hospital transport, etc.)
Reason for recall
The End-Tidal CO2 (EtCO2) reading can intermittently show a value of XXX after start-up or during device operation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1143-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.